Streptococcus salivarius K12 Probiotic Reduced Severe Radiation-Associated Oral Mucositis Among Patients With Head and Neck Cancer

According to a clinical trial, Streptococcus salivarius K12 (SsK12) probiotic significantly reduced the incidence, onset, and duration of severe oral mucositis with a good safety profile among patients undergoing radiotherapy to treat head and neck cancer.

While radiotherapy is an important treatment modality for patients with malignant tumors of the head and neck, “various acute oral complications persist” and oral mucositis “is one of the most common acute radiation-related toxicities,” as Xingchen Peng, MD, Cancer Center, Sichuan University, Chengdu, China, and coauthors wrote. They went on, “Microbiota plays a pivotal role in the development and progression of radiation-induced [oral mucositis]” and recent studies have suggested “rescuing or countering the alterations of specific taxa would be promising for the management of this disease.”

In this phase 2 double-blind trial, 160 patients with malignant head and neck tumors who were undergoing definitive or postoperative radiotherapy were randomized to receive SsK12 probiotic (n = 80) or placebo (n = 80). The SsK12 probiotic was administered in the form of a lozenge with patients instructed to suck on the lozenge three times daily for the entirety of their radiotherapy period. The primary end point of the study was the incidence of severe oral mucositis.

The incidence of severe oral mucositis in the SsK12 arm was 36.6% compared with 54.2% in the placebo group, representing a significant difference (P = .0351). Additionally, the duration of and time to develop severe oral mucositis were improved among the SsK12 arm. Adverse events were similar between groups. There were 2 patients in the SsK12 arm who experienced mile or moderate gastrointestinal reactions associated with the lozenges.

Dr Peng et al, concluded, “topical application of SsK12 significantly reduces the incidence of [severe oral mucositis] in patients undergoing [radiotherapy] as compared with those who receive placebo. The development of [severe oral mucositis] is delayed, and its duration is also shortened after the administration of SsK12.”

Source:

Peng X, Li Z, Pei Y, et al. Streptococcus salivarius K12 alleviates oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors: A randomized controlled trial. J Clin Oncol. Published on January 12, 2024. doi: 10.1200/JCO.23.00837